MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reported problem was confirmed.The scope biopsy port was observed detached.

Event Description

A user facility reported to olympus that the instrument channel port seal was worn and appeared to detach from the port.In addition, it was reported that the lens was observed with "black vertical lines and black streaks." the problem, as reported to olympus, was identified during reprocessing.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.As a result of the physical inspection and functional testing of the device olympus has concluded that the damage to the device was likely caused by improper handling.There is a possibility that damage (looseness, deformation) occurred because excessive external force was applied when installing and removing the forceps/irrigation plug in or from the instrument channel port.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instructions for use states: oes cystonephrofiberscope cyf-5/cyf-5a.Chapter 9 storage.9.1 storage.Prior to storage, detach all removable parts from the endoscope.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11305218
• MDR Text Key: 241754925
• Report Number: 8010047-2021-02450
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411144
• UDI-Public: 04953170411144
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1